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Preoperative Octreotide Treatment of Acromegaly
Plain-language guide to NCT00521300: phase 4 randomized trial of Octreotide, 62 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00521300
- Phase
- phase 4
- Status
- completed
- Start
- 1999-09
- Completion (planned or actual)
- 2005-06
- Participants
- 62 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Acromegaly
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Octreotide.
It had two arms (groups): octreotide (experimental) and standard surgery (active comparator).
6 months preoperative treatment with octreotide before transsphenoidal surgery for acromegaly.
Standard transphenoidal surgery soon after the diagnosis of acromegaly.
The registry classes the interventions as drug and procedure.
More on the Plan
After a baseline evaluation, patients are randomized separately for each study center in blocks of four directly to transsphenoidal surgery or to 6-month preoperative treatment with octreotide.
Patients receive transsphenoidal surgery within 28 d of the last injection.
If surgery are delayed, an extra octreotide LAR injection is given before surgery.
Who Took Part
The registry lists 62 actual participants took part.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Pituitary tumor by MRI-scan.
The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: immediate surgery indicated by usual clinical criteria; known adverse effects of octreotide; unfit for participation by any other reason.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.
The Octreotide group and the comparison group ran side by side rather than switching.
Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 1999-09 with completion listed for 2005-06.
It ran at 5 sites in Norway (5).
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Octreotide in 62 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Octreotide compound page, all human trials.
Our Notes on the Compound
Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.